- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07582445
Perioperative Prospective Follow Up Of Cannabis Consumers and Discrepancy Use
Perioperative Prospective Follow Up Of Cannabis Consumers
Study Overview
Status
Conditions
Detailed Description
This study aims to assess the proportion of cannabis users who undergo surgery. In addition, we seek to evaluate whether chronic cannabis use affects the perioperative period. Specifically, we will examine whether cannabis use around the time of surgery influences levels of pain, opioid consumption, nausea, anxiety, and sleep disturbances.
A matched control cohort with similar patient characteristics will be used for comparison.
Another key objective is to assess discrepancies between patients' self-reported cannabis use and their actual usage. This will be evaluated by comparing patient-reported data to objective measures such as blood test results and documented cannabis levels in medical records. We hypothesize that patients tend to underreport their cannabis use relative to the levels detected through clinical testing.
Following signing an informed consent, study participants will be asked to complete a preoperative questionnaire to assess their cannabis consumption habits.
Prior to anesthesia adminsatration, a 6 cc blood sample will be collected from the patient's intravenous line. This sample will be used to measure cannabis levels in the blood, allowing for a comparison between self-reported cannabis use and actual detected levels. The sample will be immediately labeled with a unique serial number in the operating room. After plasma separation via centrifugation, the sample will be frozen for later analysis using high-performance liquid chromatography (HPLC . All samples will be deidentified to external personal.
Following surgery, participants will be asked to complete questions postoperatively up to 7 days. These follow-ups will gather information on any changes in cannabis use as well as symptoms such as pain intensity, nausea, sleep quality, and use of rescue medications.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
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Jerusalem, Israel, 9210141
- Hadassah Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population will consist of patients scheduled to undergo elective surgery.
This will include individuals who regularly use cannabis, as well as a matched control cohort with similar demographics who do not use cannabis.
Description
Inclusion Criteria:
- Patients who use cannabis and are scheduled to undergo elective surgery.
- A matched control cohort of patients with similar demographics who are also scheduled for elective surgery.
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study cohort: patients undergoing elective surgery who use cannabis.
Control cohort: patients undergoing elective surgery who do not regularly use cannabis.
|
urine sample
|
|
control group
Patients undergoing elective surgery who do not use cannabis regularly
|
urine sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
discrepancy percentage between reported cannabis users and actual cannabis usage among patients undergoing elective surgery.
Time Frame: up to 7 days
|
up to 7 days
|
|
|
Use of Cannabis
Time Frame: up to 7 days postopertively
|
Doasge Use of Cannabis
|
up to 7 days postopertively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain levels during surgery as assesed using VAS
Time Frame: up to 7 days
|
We aim to assess whether pain levels during surgery are affected by cannabis use of the VAS questionaire
|
up to 7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elyad Davidson, MD, Hadassah medical center/ Hebrew univeristy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0001-25-HMO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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